Sodium NItroPrusside Treatment in Acute Heart Failure (SNIP-AHF)
Sodium NItroPrusside Treatment in Acute Heart Failure: Multicenter, Observational, Retrospective Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
-
-
Italia
-
Milano, Italia, Italy, 20162
- ASST Grande Ospedale Metropolitano Niguarda
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older
- AHF diagnosis, defined as rapid onset or worsening of symptoms and/or signs of HF. According to a recently proposed new definition, HF is a clinical syndrome with current or prior Symptoms and or signs caused by a structural and/or functional cardiac abnormality (as determined by EF <50%, abnormal cardiac chamber enlargement, E/E' >15, moderate/severe ventricular hypertrophy or moderate/severe valvular obstructive or regurgitant lesion) and corroborated by at least one of the following: Elevated natriuretic peptide levels ; Objective evidence of cardiogenic pulmonary or systemic congestion by diagnostic modalities such as imaging (e.g. by chest X-ray or elevated filling pressures by echocardiography) or haemodynamic measurement (e.g. right heart catheterization, pulmonary artery catheter) at rest or with provocation (e.g. exercise).
- Intravenous SNP treatment
Exclusion Criteria:
- Age <18 years old
- AHF after cardiac surgery
- AHF complicated by cardiogenic shock requiring high dosage (defined as inotropic score >10) vasoactive agents and/or short-term extracorporeal life support (i.e. VA-ECMO, Impella). Inotropic score (IS) calculated as: dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 100 × norepinephrine dose (μg/kg/min) + 10 × phosphodiesterase 3 inhibitor dose (μg/kg/min).
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Acute heart Failure AHF
AHF diagnosis, defined as rapid onset or worsening of symptoms and/or signs of HF
|
The primary objective of our study is to assess the efficacy and safety of SNP as part of the treatment regimen of AHF patients and to identify predictors of efficacy.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NT-pro-BNP or BNP reduction
Time Frame: 48 hours
|
Significant reduction (at least 25% from baseline levels) 48 hours after initiation of SNP infusion
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48 hours
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospitalizations
Time Frame: 6 months
|
Survival free from re-hospitalizations for heart failure
|
6 months
|
|
Mortality
Time Frame: 30 days and 6 months
|
All-cause mortality
|
30 days and 6 months
|
|
Heart replacement therapies
Time Frame: 30 days and 6 months
|
Composite of long-term LVAD implantation or HTx
|
30 days and 6 months
|
|
Intensive Care Unit
Time Frame: through study completion, an average of 6 months
|
Length of intensive care unit and total hospital stay
|
through study completion, an average of 6 months
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- S_04_06_21_5186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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